FDA (Drugs) recall action 72455
The FDA (Drugs) publishes a recall like this one as 48 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 48 pages.
Lack of Assurance of Sterility
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Downing Labs, LLC is recalling 881 vials of Procaine Injectables because the company cannot ensure the product is sterile. The affected vials were distributed in the US and 17 other countries.
Downing Labs, LLC is recalling DMPS Injectable vials because the company cannot ensure the product is sterile.
Downing Labs is recalling specific lots of Phosphatidylcholine/Deoxycholic Acid Injection because the company cannot assure the product's sterility.
Downing Labs, LLC is recalling all lots of Chromium Injectable, 200mg/mL, 30mL vials because the product lacks assurance of sterility.
Downing Labs, LLC is recalling Acetyl-L-Carnitine and L-Carnitine injectable vials due to a lack of assurance of sterility. The products were distributed nationwide and internationally.
Downing Labs, LLC is recalling 315 vials of Methylcobalamin Injection Buffered 5mg/mL due to a lack of assurance of sterility. The product was distributed nationwide and internationally.
Downing Labs, LLC is recalling 16 vials of L-Tryptophan Injectable because the company cannot assure the product's sterility.
Downing Labs is recalling 104 vials of EDTA Calcium Disodium Injectable because the company cannot assure the product's sterility.
Downing Labs, LLC is recalling 235 vials of Dexpanthenol Injection because the product lacks assurance of sterility. The recall covers all lots distributed nationwide and internationally.
Downing Labs, LLC is recalling Thiotic Acid Injection because the company cannot ensure the product is sterile. The recall affects 7 vials distributed in the US and 17 other countries.
Downing Labs, LLC is recalling DMSO 99% Injection vials because the product lacks assurance of sterility. The recall affects 187 vials distributed in the US and internationally.
Downing Labs, LLC is recalling 171 vials of TNPRDC Injection because the company cannot assure the sterility of the product. The recall covers all lots distributed nationwide and internationally.
Downing Labs, LLC is recalling 481 vials of TNPDR Injection Buffered because the company cannot ensure the product is sterile. The recall covers all lots distributed nationwide and internationally.
Downing Labs, LLC is recalling DMAE Dimethylaminoethanol Injection due to a lack of assurance of sterility. The recall affects 16 vials distributed nationwide and internationally.
Downing Labs, LLC is recalling Vitamin D3 Injectable, 10,000 U/mL, 10mL vials due to a lack of assurance of sterility. The product was distributed nationwide and internationally.
Downing Labs, LLC is recalling 74 vials of Zinc Sulfate Injection due to a lack of assurance of sterility. The product was distributed nationwide and internationally.
Downing Labs, LLC is recalling MICML TRNDPPC Injection (Preserved) 10mL vials because the company cannot ensure the product is sterile.
Downing Labs, LLC is recalling 20 vials of Glucosamine HCL Injectable because the product lacks assurance of sterility. The recall covers all lots distributed in the US and internationally.
Downing Labs, LLC is recalling 1,062 vials of HCG (Lyophilized) Injectable because the product lacks assurance of sterility. The recall covers all lots distributed nationwide and internationally.
Downing Labs, LLC is recalling Ascorbic Acid Injectable 500mg/mL vials due to a lack of assurance of sterility. The recall affects 4,857 vials distributed in the US and 17 other countries.
Downing Labs, LLC is recalling 225 vials of Potassium Chloride Injection due to a lack of assurance of sterility. The product was distributed nationwide and in multiple international markets.
Downing Labs, LLC is recalling 106 vials of Hydroxocobalamin Injection due to a lack of assurance of sterility. The product was distributed nationwide and internationally.
Downing Labs, LLC is recalling 286 vials of Calcium Gluconate Injection 10% because the company cannot ensure the product is sterile.
Downing Labs, LLC is recalling 289 vials of Magnesium Chloride Hexahydrate Injection due to a lack of assurance of sterility. The product was distributed nationwide and internationally.
Downing Labs, LLC is recalling Pyridoxine Injection, 100 mg/mL, 30mL vials due to a lack of assurance of sterility. The recall affects 280 vials distributed nationwide and internationally.